Medical systems, devices, and related methods

ABSTRACT

A device may include a first portion coupled to a shaft of an insertable medical device. The first portion may extend along a first portion longitudinal axis between a proximal end and a distal end. The first portion may include a protrusion extending radially outwardly of the first portion longitudinal axis. At least a portion of the first portion may be received within a lumen of a second portion. The second portion may be axially moveable along the first portion longitudinal axis relative to the first portion. The second portion may include a longitudinally extending channel. A spring may be located radially between the first portion and the second portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62/447,549, filed Jan.18, 2017, which is herein incorporated by reference in its entirety.

TECHNICAL FIELD

Various aspects of the present disclosure relate generally to medicalsystems, devices, and related methods. More specifically, the presentdisclosure relates to medical systems and/or devices for measuringapplied force via a shaft or elongate member of a device duringinsertion and/or withdrawal of the shaft or elongate member.

BACKGROUND

The field of endoscopy covers systems and methods a user may employ toexamine and/or treat a patient with, e.g., the assistance of anendoscope or other suitable introduction sheaths or devices. Anendoscope (or other suitable introduction device) may provide forviewing of, for example, the interior of a hollow organ or cavity in thepatient's body. Ureteroscopy, for example, may be performed to diagnoseand treat urinary tract diseases and ureteral strictures. A ureteroscopemay be inserted retrograde through the urinary tract such that diagnosisand treatment of urinary tract abnormalities may be performed. Insertionand withdrawal of a shaft of a ureteroscope or other such endoscope ormedical device must be done carefully to avoid excessive application offorce or insufficient application of force. For example, insertion of ashaft of an insertion device or medical device with too much force maycause perforation of body tissue via the shaft, while insufficient forceduring insertion may result in insufficient passage of the shaft throughor within the body of a patient. Additionally, withdrawal of a shaft ofan insertion device or medical device with too much force may causetissue damage (e.g., via removal of a sizable kidney stone) or collapseof a body lumen, while insufficient force during withdrawal may resultin insufficient retraction of the shaft from the body of a patient.

The systems, devices, and methods of the current disclosure may rectifysome of the deficiencies described above or address other aspects of theprior art.

SUMMARY

Examples of the present disclosure relate to, among other things,medical devices. Each of the examples disclosed herein may include oneor more of the features described in connection with any of the otherdisclosed examples.

In one example, a device may include a first portion coupled to a shaftof an insertable medical device. The first portion may extend along afirst portion longitudinal axis between a proximal end and a distal end.The first portion may include a protrusion extending radially outwardlyof the first portion longitudinal axis. At least a portion of the firstportion may be received within a lumen of a second portion. The secondportion may be axially moveable along the first portion longitudinalaxis relative to the first portion. The second portion may include alongitudinally extending channel. A spring may be located radiallybetween the first portion and the second portion.

Examples of the device may include one or more of the followingfeatures. The protrusion of the first portion may be received within thechannel of the second portion. The protrusion may be a first protrusion,and the first portion may include a second protrusion extending radiallyoutwardly of the first portion longitudinal axis. The second protrusionmay be spaced 180° from the first protrusion, about the first portionlongitudinal axis. The channel may be a first channel, and the secondportion may include a second longitudinally extending channel. Thesecond channel may be spaced 180° from the first channel, about thefirst portion longitudinal axis. The first portion may include a firstgrip portion, a base portion, and a transition portion between the firstgrip portion and the base portion. The base portion may have a radialdimension smaller than the first grip portion. The transition portionmay include an abutment for a first end of the spring. The secondportion may include a stop, wherein the stop may include an abutment fora second end of the spring. A cap may have a stem threadably receivedwithin a first side of a lumen of the first portion. A compressiblegrommet may be positioned axially between the stem and a second side ofthe lumen of the first portion. Each of the first portion and secondportion may include a hexagonal or octagonal outer profile. Theprotrusion may be positioned on a deflectable arm of the first portion.The second portion may include a plurality of indicia, and each of theindicia may be indicative of a force exerted by the spring on the firstportion and second portion. The first portion and the second portion maybe located on a proximalmost third of the shaft.

In a further example, a system is described. The system may include ashaft of an insertion device or a medical device and a force indicatorcoupled to the shaft. The force indicator may include a first portionextending along a first portion longitudinal axis between a proximal endand a distal end and a second portion. At least a portion of the firstportion may be received within a lumen of the second portion. The secondportion may be axially moveable along the first portion longitudinalaxis relative to the first portion and the shaft. A spring may belocated radially between the first portion and the second portion.

Examples of the system may further include one or more of the followingfeatures. The first portion of the force indicator may include aprotrusion extending radially outwardly of the first portionlongitudinal axis and the second portion may include a longitudinallyextending channel. The protrusion may be disposed within the channel andaxially translatable therein. The second portion may include a pluralityof indicia, each of the indicia may be indicative of a force exerted bythe spring on the first portion and second portion. The first portionmay include a first grip portion, a base portion, and a transitionportion between the first grip portion and the base portion, where thebase portion may have a radial dimension smaller than the first gripportion, and where the transition portion may include an abutment for afirst end of the spring. The second portion may include a stop having anabutment for a second end of the spring. The protrusion of the firstportion may be a first protrusion and the first portion may furtherinclude a second protrusion extending radially outwardly of the firstportion longitudinal axis, and where the channel of the second portionmay be a first channel, and the second portion may further include asecond longitudinally extending channel.

In a further example, a method of measuring at least one of an insertionor a withdrawal force of a shaft is disclosed. The method may includecoupling a force indicator to the shaft. The force indicator may includea first portion which may have a protrusion extending radially outwardlyof a first portion longitudinal axis and a second portion. At least aportion of the first portion may be received within a lumen of thesecond portion, and the second portion may include a longitudinallyextending channel. The force indicator also may include a spring locatedradially between the first portion and the second portion. The methodadditionally may include moving the channel of the second portionrelative to the protrusion of the first portion along the first portionlongitudinal axis and determining a force exerted by the spring on thefirst portion and the second portion by gauging the position of theprotrusion of the first portion with respect to one of a plurality ofindicia on the second portion.

Examples of the method may include one or more of the followingfeatures. Coupling the force indicator to the shaft may include fixedlycoupling the force indicator to the shaft via at least one of adhesivesor welding. Coupling the force indicator to the shaft may includeremovably coupling the force indicator to the shaft via a compressiblegrommet.

Both the foregoing general description and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the features, as claimed. As used herein, the terms “comprises,”“comprising,” or other variations thereof, are intended to cover anon-exclusive inclusion such that a process, method, article, orapparatus that comprises a list of elements does not include only thoseelements, but may include other elements not expressly listed orinherent to such a process, method, article, or apparatus. Additionally,the term “exemplary” is used herein in the sense of “example,” ratherthan “ideal.” As used herein, the terms “about,” “substantially,” and“approximately,” indicate a range of values within +/−5% of a statedvalue.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate exemplary features of the presentdisclosure and together with the description, serve to explain theprinciples of the disclosure.

FIG. 1 illustrates an exemplary insertion device including a forceindicator arranged to gauge a withdrawal force;

FIG. 2 illustrates a partial exploded view of the insertion device ofFIG. 1;

FIG. 3 illustrates a partial view of an insertion device including aforce indicator arranged to gauge an insertion force, according tofurther aspects of the disclosure;

FIG. 4 illustrates an additional exemplary partial view of an insertiondevice including a plurality of force indicators, according to furtheraspects of the disclosure; and

FIG. 5 illustrates a partial exploded view of an insertion deviceincluding an adjustable force indicator, according to further aspects ofthe disclosure.

DETAILED DESCRIPTION

Examples of the present disclosure relate to medical systems and devicesfor diagnosing and/or treating internal areas of a patient's body. Themedical system may include an insertion device and one or more medicaldevices operably coupled thereto for introduction of an end-effector orother object through the insertion device.

Reference will now be made in detail to examples of the presentdisclosure described above and illustrated in the accompanying drawings.Wherever possible, the same reference numbers will be used throughoutthe drawings to refer to the same or like parts.

The terms “proximal” and “distal” are used herein to refer to therelative positions of the components of an exemplary medical device orinsertion device. When used herein, “proximal” refers to a positionrelatively closer to the exterior of the body or closer to a medicalprofessional using the medical device or insertion device. In contrast,“distal” refers to a position relatively further away from the medicalprofessional using the medical device or insertion device, or closer tothe interior of the body.

FIG. 1 illustrates an exemplary insertion device 10 including a handle12 coupled to a shaft 14. Insertion device 10 includes any deviceconfigured to allow a medical professional to perform medical diagnosesand/or treatments on a patient. For example, insertion device 10includes any device configured to allow a user to access and viewinternal areas of a patient's body. Additionally or alternatively,insertion device 10 may itself be a medical device and/or include anydevice configured to deliver one or more medical devices, such as, forexample, biopsy forceps, graspers, baskets, snares, probes, scissors,retrieval devices, lasers, and/or other tools, into a patient's body.Insertion device 10 may be inserted into one of a variety of bodyopenings, lumens, and/or cavities. For example, insertion device 10 maybe inserted into any portion of a urinary tract, such as a ureter, agastrointestinal lumen, such as an esophagus, a vascular lumen, and/oran airway.

According to aspects of the present disclosure, insertion device 10 is aureteroscope. In some contemplated examples, insertion device 10 is asterile, single-use, and disposable ureteroscope. Alternatively,insertion device 10 is a multiple-use, non-disposable ureteroscope.Other types of devices, however, may be substituted for theureteroscope, including, as examples, a hysteroscope, a uteroscope, abronchoscope, a cystoscope, and similar devices. Such devices may besingle-use and disposable, or multiple-use.

Handle 12 of insertion device 10 may have any shape suitable forgripping and controlling insertion device 10. For example, handle 12 mayhave an ergonomic shape designed to be held comfortably in the hand,e.g., the palm of the hand of a medical professional. Shaft 14 mayextend from a proximal end 16 to a distal end 18 such that proximal end16 of shaft 14 is coupled to (e.g., detachably or permanently connectedto) a distal end of handle 12. Insertion device 10 includes a steeringmechanism for deflecting shaft 14 along one or more planes. For example,handle 12 includes an actuator 20 coupled to one or more portions ofshaft 14 at or near distal end 18 via one or more control members, suchas steering wires (e.g., Bowden cables, not shown). Any suitablesteering mechanism and/or actuators may be used. Upon manipulation ofactuator 20, a medical professional may selectively deflect distal end18 of shaft 14 in a first direction A or a second direction B along adeflection plane transverse to the longitudinal axis of handle 12. Asshown, actuator 20 may be located along an enlarged proximal end ofhandle 12. Such an enlargement may be useful to facilitate grasping ofhandle 12. For instance, when held upright, the enlarged proximal end ofhandle 12 may rest on a portion of the medical professional's hand so asto improve grasping of handle 12.

Shaft 14 includes at least one working channel (not shown) extendingbetween proximal end 16 and distal end 18 of shaft 14. In some examples,shaft 14 may include one or more electronic components, such as a cameraor other imaging device, a light source, and/or a sensor (not shown).Additionally or alternatively, shaft 14 may include a lumen for lightdelivery and/or steering control members (not shown) associated withactuator 20 for steering shaft 14.

Handle 12 also includes an umbilicus hub or connector 22 forfacilitating electrical connections and functions, such as transferringdata and/or powering a light source. In addition, handle 12 includes atleast one port 24 (e.g., a T-shaped or Y-shaped luer port connection).Port 24 includes a first branch 26. First branch 26 may be fluidlycoupled to one or more sources of irrigation and/or suction fluid.Accordingly, irrigation fluid (not shown) may be delivered (e.g.,pumped) through the working channel via first branch 26 to providelubrication and/or aid in visualization. Port 24 also includes a secondbranch 28 in communication with the working channel, e.g., to allow forthe insertion of one or more medical device(s) through the workingchannel to distal end 18 of shaft 14. For example, second branch 28 maycomprise a medical (e.g., threaded) or slip luer port through which anend-effector, control member, and/or sheath of medical device (notshown) may be delivered into second branch 28 and the working channel.

As shown in FIG. 1, a force indicator 30 is coupled to shaft 14. Forceindicator 30 may be arranged and/or positioned so as to measure at leastone of the removal force imparted to the body of a patient duringremoval or withdrawal of shaft 14 from the body, or the insertion forceimparted to the body of a patient during insertion of shaft 14 into orthrough body. In the arrangement shown in FIG. 1, force indicator 30 isarranged so as to measure the removal force imparted to the body of thepatient during removal or withdrawal of shaft 14 from the body. Forceindicator 30 may be coupled to shaft 14 along any portion of shaft 14such as, e.g., adjacent or near handle 12 and/or on or along aproximalmost third of the shaft. Further, it is understood that forceindicator 30 may be positioned closer to or further distally of handle12, but located so as to remain exterior of the body of a patient duringuse by a medical professional.

As shown in FIGS. 1 and 2, force indicator 30 includes a first portion32 fixed to shaft 14. For example, first portion 32 includes a lumen(not shown) extending therethrough within which shaft 14 is received andsecured. That is, first portion 32 may be glued, welded, or otherwisefixedly coupled to (e.g., axially fixed and not moveable along thelength of) shaft 14. Additionally, force indicator 30 includes a secondportion 34 moveable with respect to shaft 14 (e.g., not fixedly coupledto shaft 14, and is axially moveable along the length of shaft 14).Second portion 34 includes at least one slot or channel 36 within whicha pin, knob, and/or protrusion 38 of first portion 32 is positioned. Forexample, second portion 34 may include two diametrically opposedchannels 36 (e.g., two channels spaced 180° apart from one another abouta longitudinal axis of second portion 34). Additionally, first portion32 may include two diametrically opposed protrusions 38 (e.g., twoprotrusions spaced 180° apart from one another about a longitudinal axisof first portion 32), each protrusion 38 being received within acorresponding one of the two channels 36. Each protrusion 38 may extendradially outwardly (e.g., radially away from a longitudinal axis) offirst portion 32. Additionally, each protrusion 38 may be positioned ona deflectable arm 39 of first portion 32. Deflectable arms 39 extendfrom (e.g., is cantilevered from) first portion 32 such that they may bedeflected radially inwardly (e.g., toward a longitudinal axis of firstportion 32) and radially outwardly (e.g., away from a longitudinal axisof first portion 32). In order to facilitate assembly, deflectable arms39 may deflect radially inwardly as second portion 34 is moved overfirst portion 32 (e.g., as first portion 32 is received within the lumenof second portion 34). Once channels 36 align with protrusions 38,deflectable arms 39 may deflect radially outwardly to secure firstportion 32 and second portion 34 together via interaction betweenprotrusions 38 and channels 36. That is, once assembled, protrusions 38are retained within channels 36, thereby coupling first portion 32 andsecond portion 34 of force indicator 30 together.

Further, second portion 34 includes a plurality of force indicationmarkings or indicia 42A-42C. In use, second portion 34 may be movedrelative to first portion 32 such that channel 36 may move relative toprotrusion 38. In such a manner, protrusion 38 may translate alongchannel 36 and align with one of indicia 42A-42C to indicate a degree oramount of force being applied to the body of the patient, as will bedescribed in further detail below.

Each of first portion 32 and second portion 34 may have a grip surfaceon a radially external surface thereof to facilitate accurate and secureplacement of a medical professional's hand along force indicator 30. Forexample, as shown in FIGS. 1 and 2, first portion 32 includes a firstgrip portion 32A and second portion 34 includes a second grip portion34A which is shaped or otherwise configured to facilitate secure andaccurate grasping by the medical professional. That is, each of firstgrip portion 32A and second grip portion 34A may have a ribbed,hexagonal, octagonal or any other such shape. In other words, each offirst grip portion 32A and second grip portion 34A may be shaped in amanner similar to that of a shaft of a pencil. In use, torque may betransferred from the hand of a medical professional to second portion34, then to first portion 32, and then to shaft 14. Alternatively,torque may be transferred from the hand of the medical professional toan inner surface of a lumen (not shown) of the second portion 34, tofirst portion 32, and then to shaft 14.

While each of first portion 32 and second portion 34 are illustrated toinclude a grip portion, e.g., first grip portion 32A and second gripportion 34A, respectively, in some arrangements, only one or neither offirst portion 32 and second portion 34 may include such a grip portion.Additionally, while substantially the entire length of the radiallyexterior surface of second portion 34 is shown to include second gripportion 34A, in other arrangements, less than substantially the entirelength of the radially exterior surface of second portion 34 may includesecond grip portion 34A. For example, in some arrangements, second gripportion 34A may extend along about three fourths, about half, or about aquarter of the entire length of the radially external surface of secondportion 34.

Further, as shown in FIG. 2, first portion 32 includes a flange,surface, or transition portion 32B and a base portion 32C. Base portion32C includes a radial dimension (e.g., diameter) smaller than that offirst grip portion 32A while transition portion 32B is arranged axiallybetween first grip portion 32A and base portion 32C. In addition, secondportion 34 includes an abutment or stop 34B. Stop 34B may include aradially narrowed or tapered flange forming an abutment for an elasticmember or spring 40 (e.g., a helical compression spring). Spring 40 ispositioned radially between first portion 32 and second portion 34. Thatis, spring 40 may be positioned about (e.g., radially outwardly of alongitudinal axis of first portion 32) base portion 32C of first portion32, and radially inwardly of and/or within the lumen of second portion34. A proximal end of spring 40 abuts transition portion 32B of firstportion 32 while a distal end of spring 40 abuts stop 34B of secondportion 34. In such a manner, movement of second portion 32 relative tofirst portion 32 compresses or stresses spring 40.

Spring 40 includes a known spring constant k. For example, spring 40 mayhave a spring constant k selected to achieve a desired range ofrestoring force F, e.g., between about 0 lbF and about 10 lbF, orbetween about 0 lbF and about 5 lbF, or between about 0 lbF and about 3lbF. That is, spring 40 may be designed to have a selected or desiredrange of restoring force F and a particular spring constant k may beselected to achieve such a desired range of restoring force F. In oneexample, spring constant k may be between about 3 and about 15, orbetween about 5 and about 10, or about 5, or about 10. Further, spring40 may have a known free length (e.g., a total or entire length betweenthe proximal-most end and distal-most end of spring 40 when spring 40 isin a natural, unbiased, unstressed and/or neutral state). For example,spring 40 may have a free length selected to achieve a desired range ofrestoring force F. That is, as noted above, spring 40 may be designed tohave a selected or desired range of restoring force F and a particularfree length may be selected to achieve such a desired range of restoringforce F. In one example, the free length may be between about 0.5 inches(1.27 cm) and about 3 inches (7.62 cm), between about 1 inch (2.54 cm)and about 2 inches (5.08 cm), about 1 inch (2.54 cm), or about 1.3inches (3.302 cm). Additional variables may also be selected so as toachieve a desired range of restring force F. Such variables may includespring wire diameter, spring outside diameter, number of active coils,total number of coils, spring material, etc.

Accordingly, a restoring force F of spring 40 may be calculated usingHooke's Law in which the restoring (e.g., reaction) force F exerted byspring 40 on an object that is tensioning or compressing spring 40(e.g., the medical professional and/or first portion 32 and secondportion 34) by some distance X is proportional to that distance.

That is:

F=−kX

where k is the spring constant, e.g., the stiffness of spring 40, and Xis the length of deformation of spring 40.

During withdrawal of shaft 14 from the body of a patient, the medicalprofessional may grasp second grip portion 34A and pull second gripportion 34A in the direction G, as shown in FIG. 1. Upon overcoming aninitial load of spring 40 (e.g., the load experienced by spring 40 whenprotrusion 38 is aligned with first indicia 42A, or a load on spring 40due to being positioned between first portion 32 and second portion 34of force indicator 30), second portion 34 will move in the direction Gsuch that first indicia 42A is moved proximally of protrusion 38 whilesecond indicia 42B is move into alignment with or closer to protrusion38. That is, as a medical professional retracts second portion 34proximally in the direction G, he or she will overcome the initialspring bad of spring 40 until second indicia 42B is aligned withprotrusion 38 thereby indicating an increase in withdrawal force isbeing exerted to the body of the patient. Upon application of larger(e.g., greater magnitude) force in the direction G, second portion 34will move in the direction G such that second indicia 42B is movedproximally of protrusion 38 while third indicia 42C is moved intoalignment with or closer to protrusion 38. That is, as a medicalprofessional further retracts second portion 34 proximally in thedirection G, he or she will overcome the spring load of spring 40 whenprotrusion 38 is aligned with second indicia 42B until third indicia 42Cis aligned with one protrusion 38 thereby indicating an additionalincrease in withdrawal force is being exerted to the body of thepatient.

In other words, when protrusion 38 is aligned with first indicia 42A,spring 40 is subject to an initial load. When protrusion 38 is alignedwith second indicia 42B, the medical professional is applying a force tothe body of the patient via shaft 14 and spring 40 equal to thecompression force of spring 40 when compressed by a length differencebetween first indicia 42A and second indicia 42B. When protrusion 38 isaligned with third indicia 42C, the medical professional is applying aforce to the body of the patient via shaft 14 and spring 40 equal to thecompression force of spring 40 when compressed by a length differencebetween first indicia 42A and third indicia 42C. The spacing betweenfirst indicia 42A, second indicia 42B, and third indicia 42C may beselected to correspond with a desired level of force being applied tothe body of the patient during withdrawal. Additionally, while spacingbetween indicia 42A-42C is illustrated as equal, the disclosure is notso limited. In some arrangements, an axial length along second portion34 between first indicia 42A and second indicia 42B may be longer thanan axial length along second portion 34 between second indicia 42B andthird indicia 42C, or vice versa. Additionally, while only three indicia42A-42C are illustrated, the disclosure is not so limited. For example,second portion 34 may include greater or fewer indicia markings such as,e.g., between about 2 and about 10 indicia markings.

As noted above, force indicator 30 may be arranged and/or positioned soas to measure at least one of the removal force imparted to the body ofa patient during removal or withdrawal of shaft 14 from the body of thepatient, or the insertion force imparted to the body of a patient duringinsertion of shaft 14 into or through the body. While force indicator 30of FIGS. 1 and 2 is illustrated to measure the withdrawal force, in afurther arrangement, as shown in FIG. 3, force indicator 30 may bearranged to measure insertion force imparted to the body of a patientduring insertion of shaft 14 into or through body. In so doing, thedirection of force indicator 30 may be reversed. In other words, ratherthan first grip portion 32A of first portion 32 being arrangedproximally of base portion 32C of first portion 32, in the arrangementshown in FIG. 3, first grip portion 32A of first portion 32 is arrangeddistally of base portion 32C of first portion 32. In such a manner,during insertion of shaft 14 into the body of a patient, the medicalprofessional may grasp second grip portion 34A and push second gripportion 34A in the direction L, as shown in FIG. 3. It is understoodthat direction L is opposite of direction G shown in FIG. 1. Uponovercoming an initial load of spring 40 (e.g., the load experienced byspring 40 when protrusion 38 is aligned with first indicia 42A, or aload on spring 40 due to being positioned between first portion 32 andsecond portion 34 of force indicator 30), second portion 34 will move inthe direction L such that first indicia 42A is moved distally ofprotrusion 38 while second indicia 42B is move into alignment with orcloser to protrusion 38. That is, as a medical professional advancessecond portion 34 distally in the direction L, he or she will overcomethe initial spring load of spring 40 until second indicia 42B is alignedwith protrusion 38 thereby indicating an increase in insertion force isbeing exerted to the body of the patient. Upon application of larger(e.g., greater magnitude) force in the direction L, second portion 34will move in the direction L such that second indicia 42B is moveddistally of protrusion 38 while third indicia 42C is moved intoalignment with or closer to protrusion 38. That is, as a medicalprofessional further advances second portion 34 distally in thedirection G, he or she will overcome the spring load of spring 40 whenprotrusion 38 is aligned with second indicia 42B until third indicia 42Cis aligned with one protrusion 38 thereby indicating an additionalincrease in insertion force is being exerted to the body of the patient.In other words, when protrusion 38 is aligned with first indicia 42A,spring 40 is subject to an initial load. When protrusion 38 is alignedwith second indicia 423, the medical professional is applying a force tothe body of the patient via shaft 14 and spring 40 equal to thecompression force of spring 40 when compressed by a length differencebetween first indicia 42A and second indicia 42B. When protrusion 38 isaligned with third indicia 42C, the medical professional is applying aforce to the body of the patient via shaft 14 and spring 40 equal to thecompression force of spring 40 when compressed by a length differencebetween first indicia 42A and third indicia 42C.

FIG. 4 illustrates an additional arrangement in which a plurality offorce indicators are arranged along shaft 14. Indeed, as shown, a firstforce indicator 30A may be arranged so as to measure the removal forceimparted to the body of the patient during removal or withdrawal ofshaft 14 from the body. Additionally, a second force indicator 30B maybe arranged to measure insertion force imparted to the body of a patientduring insertion of shaft 14 into or through body. That is, in thearrangement shown in FIG. 4, during insertion of shaft 14 into the bodyof a patient, a medical professional may grasp second grip portion 34Aof second force indicator 30B, and advance second portion 34 in thedirection L, in a manner similar to that as described in connection withFIG. 3. During withdrawal of shaft 14 from the body of a patient, amedical professional may grasp second grip portion 34A of first forceindicator 30A, and retract second portion 34 in the direction G, in amanner similar to that as described in connection with FIGS. 1 and 2.

As noted in each of the arrangements of FIGS. 1-4, first portion 32 isfixedly coupled to shaft 14. That is, first portion 32 may be glued,welded, or otherwise fixedly coupled to (e.g., axially fixed and notmoveable along the length of) shaft 14. In an alternative arrangement,as shown in FIG. 5, a first portion 132 of a force indicator 130 may beselectively coupleable and uncoupleable from shaft 14. The forceindicator 130 of FIG. 5 includes similar features to that of FIG. 1 andaccordingly, like parts will be numbered with the same reference numberplus 100. That is, force indicator 130 includes a first portion 132, asecond portion 134, and a spring 140 therebetween. Rather than beingfixedly coupled to shaft 14 in a manner similar to first portion 32,first portion 132 includes a cap 150 and compressible grommet 152 forselectively coupling and uncoupling first portion 132 to or from shaft14. Cap 150 defines a lumen (not shown) extending therethrough andwithin which shaft 14 may be received. Additionally, cap 150 includes athreaded stem 154 which may be received within a lumen (not shown) offirst portion 132. At least a portion of the lumen of first portion 132may be similarly threaded for engagement with stem 154 of cap 150.Additionally, grommet 152 may be comprised of a compressible materialsuch as, e.g., rubber. Upon threading or otherwise coupling stem 154 ofcap 150 in the lumen (not shown) of first portion 132, grommet 152 maycompress, pinch, or otherwise grip shaft 14. In such a manner, shaft 14may be fixedly coupled to force indicator 130. Additionally, unscrewingor otherwise uncoupling cap 150 from first portion 132 may enablegrommet 152 to release shaft 14. As such, a position of shaft 14relative to force indicator 130 may be adjusted, as needed.Additionally, while force indicator 130 is arranged for measuringwithdrawal force, e.g., in a similar direction as that of forceindicator 30 of FIGS. 1 and 2, the disclosure is not so limited. Rather,any of the arrangements of FIGS. 1-4 may be arranged to include areleasable cap 150 and grommet 152 of FIG. 5.

In use, a medical professional may grasp one force indicator 30, 130 soas to gauge an insertion or withdrawal force of shaft 14. In such amanner, the medical professional will be readily provided with a visualaid depicting the degree of force imparted to the body of a patient. Asthe force indicator provides real-time information to the medicalprofessional during use, he or she may readily adjust an insertion orwithdrawal force, as appropriate to avoid unnecessary trauma to apatient.

While principles of the present disclosure are described herein withreference to illustrative examples for particular applications, itshould be understood that the disclosure is not limited thereto. Thosehaving ordinary skill in the art and access to the teachings providedherein will recognize additional modifications, applications,embodiments, and substitution of equivalents all fall within the scopeof the features described herein. Accordingly, the claimed features arenot to be considered as limited by the foregoing description.

We claim:
 1. A device, comprising: a first portion coupled to a shaft ofan insertable medical device and extending along a first portionlongitudinal axis between a proximal end and a distal end, the firstportion including a protrusion extending radially outwardly of the firstportion longitudinal axis; a second portion, at least a portion of thefirst portion being received within a lumen of the second portion,wherein the second portion is axially moveable along the first portionlongitudinal axis relative to the first portion, wherein the secondportion includes a longitudinally extending channel; and a springlocated radially between the first portion and the second portion. 2.The device of claim 1, wherein the protrusion of the first portion isreceived within the channel of the second portion.
 3. The device ofclaim 1, wherein the protrusion is a first protrusion, and the firstportion includes a second protrusion extending radially outwardly of thefirst portion longitudinal axis, wherein the second protrusion is spaced180° from the first protrusion, about the first portion longitudinalaxis.
 4. The device of claim 1, wherein the first portion and the secondportion are located on a proximal most third of the shaft.
 5. The deviceof claim 1, wherein the channel is a first channel, and the secondportion includes a second longitudinally extending channel, wherein thesecond channel is spaced 180° from the first channel, about the firstportion longitudinal axis.
 6. The device of claim 1, wherein the firstportion includes a first grip portion, a base portion, and a transitionportion between the first grip portion and the base portion, wherein thebase portion has a radial dimension smaller than the first grip portion.7. The device of claim 6, wherein the transition portion includes anabutment for a first end of the spring.
 8. The device of claim 7,wherein the second portion includes a stop, wherein the stop includes anabutment for a second end of the spring.
 9. The device of claim 1,further including: a cap having a stem threadably received within afirst side of a lumen of the first portion; and a compressible grommetpositioned axially between the stem and a second side of the lumen ofthe first portion.
 10. The device of claim 1, wherein the second portionincludes a plurality of indicia, each of the indicia indicative of aforce exerted by the spring on the first portion and second portion. 11.A system, comprising: a shaft of an insertion device or a medicaldevice; and a force indicator coupled to the shaft, the force indicatorincluding: a first portion extending along a first portion longitudinalaxis between a proximal end and a distal end; a second portion, at leasta portion of the first portion being received within a lumen of thesecond portion, wherein the second portion is axially moveable along thefirst portion longitudinal axis relative to the first portion and theshaft; and a spring located radially between the first portion and thesecond portion.
 12. The system of claim 11, wherein the first portion ofthe force indicator includes a protrusion extending radially outwardlyof the first portion longitudinal axis and the second portion includes alongitudinally extending channel.
 13. The system of claim 12, whereinthe protrusion is disposed within the channel and axially translatabletherein.
 14. The system of claim 11, wherein the second portion includesa plurality of indicia, each of the indicia indicative of a forceexerted by the spring on the first portion and second portion.
 15. Thesystem of claim 11, wherein the first portion includes a first gripportion, a base portion, and a transition portion between the first gripportion and the base portion, wherein the base portion has a radialdimension smaller than the first grip portion; and wherein thetransition portion includes an abutment for a first end of the spring16. The device of claim 15, wherein the second portion includes a stop,wherein the stop includes an abutment for a second end of the spring.17. The device of claim 12, wherein the protrusion of the first portionis a first protrusion, the first portion further including a secondprotrusion extending radially outwardly of the first portionlongitudinal axis, and wherein the channel of the second portion is afirst channel, the second portion further including a secondlongitudinally extending channel.
 18. A method of measuring at least oneof an insertion or a withdrawal force of a shaft; coupling a forceindicator to the shaft, the force indicator including: a first portionhaving a protrusion extending radially outwardly of a first portionlongitudinal axis; a second portion, at least a portion of the firstportion being received within a lumen of the second portion, wherein thesecond portion includes a longitudinally extending channel; and a springlocated radially between the first portion and the second portion;moving the channel of the second portion relative to the protrusion ofthe first portion along the first portion longitudinal axis; anddetermining a force exerted by the spring on the first portion and thesecond portion by gauging the position of the protrusion of the firstportion with respect to one of a plurality of indicia on the secondportion.
 19. The method of claim 18, wherein coupling the forceindicator to the shaft includes fixedly coupling the force indicator tothe shaft via at least one of adhesives or welding.
 20. The method ofclaim 18, wherein coupling the force indicator to the shaft includesremovably coupling the force indicator to the shaft via a compressiblegrommet.